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Clinical trials for Coagulation factor VII

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    26 result(s) found for: Coagulation factor VII. Displaying page 2 of 2.
    « Previous 1  2 
    EudraCT Number: 2021-004009-37 Sponsor Protocol Number: MD2021.01 Start Date*: 2021-11-05
    Sponsor Name:Prothya Biosolutions BV
    Full Title: A Phase 1/2 study of the dose-response in pharmacodynamics and safety of prothrombin complex concentrate Cofact in healthy subjects under vitamin K antagonist anticoagulation
    Medical condition: Treatment of bleeding and perioperative prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004866 10005103 Bleeding LLT
    21.0 10042613 - Surgical and medical procedures 10036898 Prophylaxis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003041-41 Sponsor Protocol Number: 012507 Start Date*: 2018-11-16
    Sponsor Name:Queen Mary University of London
    Full Title: A pragmatic pilot randomised controlled trial of Prothrombin Complex Concentrate (PCC) versus Fresh Frozen Plasma (FFP) in adult patients who are undergoing Heart Surgery
    Medical condition: Major bleeding during cardiac surgery not related to vitamin K antagonists
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004863 10051536 Intraoperative bleeding LLT
    20.1 100000004863 10036277 Postoperative bleeding LLT
    21.1 10042613 - Surgical and medical procedures 10042609 Surgery PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-004879-35 Sponsor Protocol Number: NN1731-1804 Start Date*: 2007-11-19
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-centre, randomised, double-blinded, controlled, dose-escalation trial on safety and efficacy of activated recombinant FVII analogue (NN1731) in the treatment of joint bleeds in congenital h...
    Medical condition: Haemophilia A with anti factor VIII and Haemophilia B with anti factor IX
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056492 Haemophilia A with anti factor VIII LLT
    9.1 10056494 Haemophilia B with anti factor IX LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) HU (Completed) IT (Prematurely Ended) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-002059-41 Sponsor Protocol Number: F7Trauma-1711 Start Date*: 2005-07-07
    Sponsor Name:Novo Nordisk A/S
    Full Title: A multi-center, randomized, double-blind, parallel group, placebo controlled trial to evaluate the efficacy and safety of activated recombinant factor VII (rFVIIa/NovoSeven®/NiaStase®) in severely ...
    Medical condition: Traumatic Hemorrhage
    Disease: Version SOC Term Classification Code Term Level
    8.0 10053476 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) BE (Completed) GB (Completed) ES (Completed) CZ (Completed) IT (Completed) FI (Completed) SE (Completed) PT (Prematurely Ended) SI (Completed) GR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2019-003722-25 Sponsor Protocol Number: U1111-1201-0087 Start Date*: 2020-12-14
    Sponsor Name:University of Cincinnati
    Full Title: rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial
    Medical condition: Acute haemorrhagic stroke
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004852 10048863 Hemorrhagic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2004-004202-24 Sponsor Protocol Number: F7ICH-1641 Start Date*: 2005-04-29
    Sponsor Name:Novo Nordisk A/S
    Full Title: Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral ...
    Medical condition: Acute Intracerebral Haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    7.1 10022753 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) SE (Completed) NO (Completed) DK (Completed) IT (Completed) BE (Completed) AT (Completed) GB (Completed) ES (Completed)
    Trial results: View results
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    Query did not match any studies.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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